NeuroPace, Inc. announced that on February 22, 2013 the U.S. Food and Drug Administration (FDA) Neurological Devices Panel voted unanimously (11 to 0 with two abstentions) that the clinical benefits of the NeuroPace RNS System outweigh the risks of its use. NeuroPace is seeking approval for the RNS System for treating adults with partial onset seizures that have not been controlled with two or more antiepileptic medications. The final decision regarding approval of the device is made by the FDA. The RNS System has been evaluated in three clinical trials, including the prospective, randomized, double blinded, sham-stimulation controlled pivotal study. The pivotal study primary effectiveness endpoint was met by demonstrating a 37.9% reduction in seizure frequency in the treatment group compared to a 17.3% reduction in the sham-stimulation control group during a three month blinded evaluation period. This difference was statistically significant (p=0.012). Long-term results demonstrated sustained improvements in seizure frequency with median seizure frequency reductions of 44% and 53% at one and two years post-implant, respectively.

NeuroPace, Inc. Presents at 2012 Epilepsy Pipeline Update Conference, Feb-03-2012 10:30 AM. Venue: Hyatt Regency Hotel, 5 Embarcadero Center, San Francisco, CA 94111, United States. Speakers: Martha J. Morrell, Chief Medical Officer.